Gastric bypass surgery can treat obesity. Recently, it was found that, for an obese patient undergoing the surgery, not only the body weight was significantly decreased, but also the type 2 diabetes complicated by obesity was alleviated (Chinese Journal of Diabetes, 2011, 3(3): 205-208): after the surgery, the blood sugar problem could be solved without injecting insulin or taking multiple medicaments, and hypertension, obesity, blood lipid disorders and other diabetic complications could be further obviously improved. According to the analysis of 22094 cases of the gastric bypass surgery: 84% of the patients suffering from the type 2 diabetes completely reversed after the surgery, and most of the patients stopped the treatment with oral medicaments or insulin before leaving the hospitals (Chinese Medical Science, 2011, 1 (21): 3-5). Foreign countries including the US government have been actively promoting the development of the surgery. In March, 2011, in the 2nd International Conference of Interventional Treatment of Type 2 Diabetes held in New York, US, the International Diabetes Federation (IDF) firstly issued a statement that, it was considered that the gastric bypass surgery can be used for treating the obese patients suffering from the type 2 diabetes and could reduce the occurrence and development of chronic complications of the diabetes (Chinese Medical Science, 2011, 1 (22): 1-2), and if the surgery was performed early, the serious complications of the diabetes could also be prevented (Diabetes World: Abstracts Journal, 2011, 10: 51).
However, the “gastric bypass surgery” has clinical risks, such as death, intestinal obstruction, anastomotic leakage, pulmonary embolism, deep vein thrombosis, portal vein injury, diseases of respiratory system and the like (Chinese Journal of Diabetes, 2011, 3 (3): 205-208). Thus, the way of placing the covering membrane within the duodenum in the duodenum in vivo for preventing and treating the obesity and the diabetes has an application significance for replacing the “gastric bypass surgery”.
In the invention patent of “duodenal sleeve and conveyor thereof” (application date: Apr. 9, 2010 and date of authorized announcement: Jan. 11, 2012) in the prior art, although a disposable static “expanded” metal framework which covers an outer sleeve and only depends on “a memory alloy” is “fully close to” the intestinal wall and “the metal framework of a duodenal bulb cavity section” which is shaped like a “bowl and funnel” is “jointed with the duodenal bulb cavity”, the duodenum is mobile, particularly when the gastric pylorus expands and draws the duodenal bulb which is just below the gastric pylorus to expand on the upper edge of the duodenal bulb, the metal framework is difficult to perform elastic expansion and accordingly move to the distal end of the duodenum, and when the gastric pylorus retracts, the metal framework may perform reverse reset (the mucosa of the duodenal bulb is relatively thin and is the predilection site of ulcers; and if the process is repeated in such a way, the mucosa is liable to injuries, and a muscular wall stretch receptor is liable to stimulation, thereby being liable to inducing nausea or/and vomiting [Zhou Lv, Ke Meiyun: Gastrointestinal Dynamics: Base and Clinic page 117] or perform incarceration at the distal end of the duodenal bulb by flexible intestinal compensative expansion. “The top end of the metal framework terminates on the side of the duodenal papilla near the pylorus”, although it “does not hinder effluent of the bile and pancreatic duct from flowing out and entering the intestinal cavity”, the back section of the metal framework duodenal bulb is “fully close to” the intestinal wall, and the duodenal papilla at a common opening of the common bile duct and the pancreatic duct at the lower end of the duodenal descending part is also blocked.
In order to solve the problem of fixation, according to the prior art (utility model patent of “sleeve placed in duodenum-jejunum” with the application date of Dec. 6, 2010 and date of authorized announcement of Sep. 28, 2011), a hollow metal tube is made into a spike fixing claw, which is “sleeved on metal wires of an annular stent” and is tightly “fixed”. Then, in order to solve the removal problem in the future, according to the prior art (utility model patent of “sleeve placed in duodenum-jejunum”), a tightening thread is further designed, wherein the tightening thread is “placed at the top of the annular stent”, and “can be wound around an upper opening for one circle or multiple circles”, but by implanting the sleeve in vivo, particularly under the situation of only considering that the spike fixing claw made of the hollow metal tube on the static annular stent with “simplicity and convenience in manufacturing and tightening performance” is pierced into the inner wall of the duodenal bulb cavity, and along with the gastrointestinal motion, looseness, exudation and adhesion are repeated continuously. According to the prior art (utility model patent of “sleeve placed in duodenum-jejunum”), the material of a flexible tube only considers “smooth surface, softness and compactness”, the adaptive elastic expansion and contraction of the annular stent to the movements of the duodenal bulb and the adoption of the elastic material for preparing the flexible tube are not involved in the patent; and the tightening thread without elasticity which is “fixed” at “the top of the annular stent” on the upper edge of the duodenal bulb even limits the compliance of the annular stent to the movements of the duodenal bulb. Compared with the invention patent of “duodenal sleeve and conveyor thereof” in the prior art, in the prior art (utility model patent of “sleeve placed in duodenum-jejunum”), as the annular stent and the spike fixing claw are only positioned in the duodenal bulb, although the duodenal papilla at the common opening of the common bile duct and the pancreatic duct at the lower end of the duodenal descending part is not blocked, but if they are placed on the upper edge of the duodenal bulb, when the gastric pylorus expands or retracts to draw the duodenal bulb which is just below the gastric pylorus to move (Zhou Lv, Ke Meiyun: Gastrointestinal Dynamics: Base and Clinic pages 381, 520 and 522), the annular stent and the spike fixing claw are bound to hinder the movements of the duodenal bulb, particularly when the gastric pylorus expands to draw the duodenal bulb to move, the annular stent and the spike fixing claw cannot accordingly expand, the spike fixing claw pierced into the mucosa of the duodenal bulb also inwards and centrically pulls the mucosal tissue of the duodenal bulb to be opposite to the movements of muscle tissue and other tissues below the mucosa of the duodenal bulb, which are expanded outwards and centrifugally as a whole, and obviously, when the gastric pylorus expands or retracts to draw the duodenal bulb which is just below the gastric pylorus to move, such annular stent and the spike fixing claw which cannot change or change a little accordingly can cause injuries to the duodenal bulb; and if they are placed on the lower edge of the duodenal bulb, although the drawing of the lower edge of the duodenal bulb by expansion or retraction of the gastric pylorus is less than the drawing of the upper edge of the duodenal bulb, even the injuries to the mucosa of the duodenal bulb caused by the annular stent and the spike fixing claw thereof are ignored, the original effect of blocking the duodenal bulb also disappears accordingly.
In the prior art (utility model patent of “sleeve placed in duodenum-jejunum” with application date of Dec. 6, 2010 and date of authorized announcement of Sep. 28, 2011), the metal wires of the annular stent are continuous like V, the elasticity of such model is weaker than that of the model which arranges single-circle coil springs in V-shaped peaks, valleys and bent angles and is prepared from the same material by the same preparation method, the sharp injuries of the model are stronger than that of the model which arranges the single-circle coil springs in the V-shaped peaks, the valleys and the bent angles and is prepared from the same material by the same preparation method, the fixation of “scissors open” against buckling threads or recovery threads attached thereon of such model is also poorer than that of the model which arranges the single-circle coil springs in the V-shaped peaks, the valleys and the bent angles and is prepared from the same material by the same preparation method, and the fixation against the buckling threads or the recovery threads in the intestinal cavity of the duodenum performing telescopic motion in the transverse diameter and conveying chyme in the longitudinal diameter is poorer, thereby being not conductive to anatomical structure and basic physiological functions.